1. Field of the Invention
The present invention relates to a method of manufacturing a small medical devices from hollow workpieces, and more particularly, relates to a method which may be used to manufacture very small, thin-walled, tubular devices such as embolic coil retrievable devices, or stents.
2. Description of the Prior Art
For many years, small medical devices such as dilatation balloons, stents and vasculature occlusion devices have been placed within the vasculature of the body. One such occlusion device used for occlusion of a vessel or of an aneurysm is an embolic coil. More recently, such devices have been manufactured to be of a size sufficiently small such that these devices may be placed into vessels of the human brain.
Examples of such catheter-based medical devices are disclosed in U.S. Pat. No. 5,108,407, entitled xe2x80x9cA Method And Apparatus For Placement Of An Embolic Coil;xe2x80x9d U.S. Pat. No. 5,122,136, entitled, xe2x80x9cEndovascular Electrically Detachable Guidewire Tip For The Electroformation Of Thrombus In Arteries, Veins, Aneurysms, Vasculature Malformations And Arteriovenous Fistulas.xe2x80x9d These patents disclose embolic coils and devices for placing the coils at selected positions within a vessel of the brain in order to treat aneurysms, or alternatively, to occlude a blood vessel at a particular location.
Stents have also been placed within vessels of the brain. Such devices may take the form of a helically wound wire or tubular like structures formed by removing patterns of material from the walls of a tube in order to define a generally skeletal structure.
Stents are generally formed of materials that maintain their shape under the pulsatile flow conditions encounters when placed within a vessel of the body. Some materials that have been used to make such stents include metals and alloys, such as for example, stainless steel, tantalum, tunston and nitinol.
In the event a decision is made to remove an embolic coil from a vessel a coil retrieval system is inserted into the vasculature, such as a vessel of the brain, in order to retrieve the embolic device. Generally, the coil retrieval system includes a grasping mechanism mounted on the distal tip of a catheter. The grasping mechanism is used to grasp and contain a coil and is generally formed for the use of two or more jaws which are normally biased outwardly. When this grasping mechanism is placed within a positioning catheter the jaws are urged to a closed position in order to permit the retrieval device to be passed through the vasculature of the body to a position adjacent to the coil. Once the distal end of the positioning catheter is placed adjacent to the coil, the grasping mechanism is moved out of the catheter to thereby cause the arms to open for subsequent capture of the coil. The gripping mechanism is then withdrawn into the catheter thereby causing the arms to latch, or grip, the coil for removal from the vessel.
In the manufacture of certain small medical devices, such as stents, lathes have been used to support a tubular workpiece used to form the stent during the cutting process. Typically a piece of tubing is supported between a drive mechanism and a tail stock support in lathe. A laser cutting beam is positioned above the tubing to cut a preselected pattern by moving the beam relative to the tubing along the length of the stent. The tubing is then rotated, as necessary, in order to cut along the entire circumference of the tubular workpiece. After the pattern is completely cut, the tubing is cut first at the tail stock end and then at the drive end to form a finished stent. This laser cutting technique for manufacturing stents has proven to be very satisfactory for the manufacture of such medical devices of a size to be used in coronary arteries of the body. Such stents generally have an outer diameter of on the order of about 0.041 inches. Examples of such a laser cutting apparatus and method of use are illustrated in U.S. Pat. No. 5,852,277, entitled, xe2x80x9cLaser Cutting Tool For Cutting Elongated Hollow Workpiecesxe2x80x9d and U.S. Pat. No. 6,114,653, entitled, xe2x80x9cMethod Of Cutting Hollow Workpieces With A Laser.xe2x80x9d
On the other hand, it has been found that in order to manufacture very small medical devices, such as stents or embolic coil retrieval devices, to be used in the very small, vessels of the brain, known laser cutting techniques have several limitations. For example, to manufacture such small devices, it is necessary that the diameter of the initial tubular workpiece be very small. At this small initial tube diameter, when metal is cut from the wall of the tube, some molten residual metal is forced to the interior of the tube, thereby lodging in the inner lumen of the workpiece. It is extremely difficult to remove such material, or debris, from the inside of the tube. In addition, it is very difficult to cut through one of the walls of such a small tube by use of laser cutting without damaging the opposite wall of the tube.
This invention relates to a method for cutting a pattern along the length of a thin-walled, hollow workpiece, to form a small profile medical device, such as a small stent or embolic coil retrieval device, which is more reliable and is more exact.
In accordance with one aspect of the present invention, there is provided a method of manufacturing small profile medical devices from generally tubular workpieces comprising the steps of generating a laser beam to be used for cutting, cutting through the surface of a tubular workpiece of a first predetermined diameter with said laser beam to form a pattern cut along the circumference of the workpiece, radially compressing the tubular workpiece so as to reduce the diameter of the workpiece to a second diameter smaller than the first predetermined diameter, and heating the tubular workpiece to a temperature sufficient to heat set the tubular workpiece to thereby fix the diameter of the tubular workpiece at the smaller diameter.
In accordance with another aspect of the present invention, the cutting step forms a pattern cut which results in the removal of multiple diamond-shaped sections from the surface of the tubular workpiece.
In accordance with still another aspect of the present invention, the tubular workpiece is comprised of a nickel-titanium alloy, such as nitinol.
In accordance with still another aspect of the present invention, after being compressed the tubular member is heated to a temperature necessary to heat set nitinol material. In accordance with still another aspect of the present invention, the tubular member after being compressed is heated to about 450 degrees centigrade for about three minutes in order to heat set the workpiece.
In accordance with still another aspect of the present invention, the cutting step is performed in a manner to cause the material removed from the tubular workpiece to be of a configuration to form the workpiece into a tubular skeleton to prior to the workpiece being radially compressed.
The purpose of this invention is to make a small profile medical device which is very difficult to accurately fabricate by laser cutting a small tube. One of the problems associated with cutting a small tube is that since the inside dimension of the tube is so small that when material is removed from the wall, this material is forced inside of the tube thereby clogging the tube. It is extremely difficult, if not impossible to remove this debris from the inside of the tube. This invention relates to laser cutting a larger tube and then xe2x80x9cdown sizingxe2x80x9d the tube through compression and heat setting. The initial tube size may be 0.048 inches and the resulting medical device may have an outside diameter of 0.016 inches.